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    Summary
    EudraCT Number:2010-020137-10
    Sponsor's Protocol Code Number:M11-271
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-020137-10
    A.3Full title of the trial
    Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos de
    tratamiento en pacientes con enfermedad de Crohn moderada a grave.
    An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    CALM
    A.4.1Sponsor's protocol code numberM11-271
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HUMIRA 40 mg solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.3Other descriptive nameADALIMUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azathioprin-ratiopharm 25mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameazathioprine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 446-86-6
    D.3.9.3Other descriptive nameAZATHIOPRINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azathioprin-ratiopharm 50 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameazathioprine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 446-86-6
    D.3.9.3Other descriptive nameAZATHIOPRINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Decortin 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Decortin 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad de Crohn.

    Crohn's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que un control estricto de la actividad de la enfermedad aplicando criterios estrictos basados en el CDAI, la hs-PCR, la calprotectina fecal y el uso de corticosteroides mejora la tasa de curación de la mucosa en la semana 56, en comparación con un control aplicando criterios menos estrictos basados en el CDAI y el uso de corticosteroides.

    To demonstrate that tight control of disease activity using stringent
    criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing at Week 56, as compared to management using less stringent criteria based on CDAI and corticosteroid use.
    E.2.2Secondary objectives of the trial
    Evaluar la farmacocinética (FC) de adalimumab tras la administración subcutánea

    To assess the pharmacokinetics (PK) of adalimumab following subcutaneous administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones y mujeres >= 18 y <= 75 años de edad en la visita basal.
    2. Diagnóstico de EC cólica o ileocólica confirmada mediante pruebas de imagen o endoscopia no más de 4 años antes la visita basal.
    3. Puntuación del CDAI >= 220 y <= 450 en la visita basal.
    4. Índice endoscópico de gravedad de la enfermedad de Crohn (CDEIS) > 6 en al menos un segmento no ileal, con presencia de úlceras, y CDEIS total > 8, en la visita de selección.
    5. hs-PCR >= 0,5 mg/dl en la visita de selección
    6. Calprotectina fecal >= 250 &#956;g/g en la visita de selección
    7. En caso de ser mujer, no estar en edad fértil, entendiéndose por tal la que lleva más de 1 año de posmenopausia o es estéril por métodos quirúrgicos (ligadura de trompas bilateral, ovariectomía bilateral o histerectomía) o, si está en edad fértil,utilizar uno de los siguientes métodos nticonceptivos durante el estudio y 150 días después de recibir la última dosis:
    - Preservativos, esponja, espumas, gelatinas, diafragma o dispositivo
    intrauterino (DIU). Los DIU pueden fallar durante el tratamiento con
    azatioprina. Se aconsejan medidas anticonceptivas alternativas o adicionales si se inicia azatioprina.
    - Anticonceptivos orales o parenterales durante 3 meses antes de la
    administración de los fármacos del estudio
    - Pareja con vasectomía
    8. Los varones deben acceder a utilizar una forma aceptable de anticoncepción,señalada anteriormente, al comienzo de la administración de azatioprina y durante 90 días después de la última dosis de este medicamento. Los varones también deben comprometerse a informar a sus parejas al respecto y comunicar cualquier embarazo al investigador.
    9. En caso de ser mujer, no amamantar durante el estudio ni durante 150 días después de la última dosis.
    10. El paciente o su representante legal deben haber firmado voluntariamente y fechado un consentimiento informado aprobado, que cumpla los requisitos de este protocolo del estudio y que haya sido aprobado por un comité de ética de investigación clínica (CEIC).
    11. Función cardíaca, renal y hepática adecuada, según lo determinado por el
    investigador principal y demostrado por los resultados de las pruebas de
    laboratorio, los cuestionarios y la exploración física de la selección, que no indiquen un proceso clínico anormal que pondría al paciente en un riesgo indebido y, en consecuencia, le impediría participar en el estudio.
    12. Los pacientes deben ser capaces de inyectarse y tomar por vía oral la medicación del estudio, o deben contar con una persona o un profesional sanitario que les ayuden en este cometido.
    E.4Principal exclusion criteria
    1. Uso previo o actual de fármacos biológicos para la enfermedad de Crohn o participación en un estudio de medicamentos biológicos 2.Uso previo o actual de inmunomoduladores (metotrexato, azatioprina,6-mercaptopurina)para la enfermedad de Crohn o participación en un estudio de inmunomoduladores 3. Uso de corticosteroides para la enfermedad de Crohn en los 6 meses previos a la selección 4. Más de un ciclo previo de corticosteroides 5.Uso de corticosteroides para la enfermedad de Crohn en los 2 años previos a la selección durante > 6 meses. 6.Pacientes que no estén recibiendo dosis estables de aminosalicilatos o antibióticos relacionados con la EC fluoroquinolonas como ciprofloxacino, derivados nitroimidazólicos como metronidazol, y rifaximina) durante al menos 4 semanas antes de la visita basal. Los pacientes deben acceder a mantener dosis estables durante todo el ensayo 7.Pacientes en tratamiento tópico para la enfermedad de Crohn. 8. Actividad deficiente o baja de la enzima tiopurina metiltransferasa (TPMT)(>= 34 nmol/g de Hb/hora) 9. Clasificación B3 de Montreal o clasificación B2 de Montreal con síntomas de obstrucción 10.Estenosis en la ileocolonoscopia en la selección con independencia de los síntomas 11.Más de una intervención de cirugía mayor para la enfermedad de Crohn en la historia clínica, o intervención quirúrgica programada para esta enfermedad. 12.Antecedente de neoplasia maligna (incluidos linfomas y leucemias) distinta del carcinoma espinocelular o basocelular no metastásico tratado con éxito o del carcinoma in situ localizado del cuello uterino. 13. Antecedentes de listeriosis, histoplasmosis, infección por el virus de la inmunodeficiencia humana (VIH), hepatitis B crónica activa, síndrome de inmunodeficiencia, enfermedad desmielinizante del sistema nervioso central (CNC) (como la mielitis),síntomas neurológicos indicativos de enfermedad desmielinizante, infección recurrente crónica, TB activa (en tto o no),infecciones graves como la sepsis e infecciones oportunistas. Prueba con DPP positiva en la selección >= 5 mm. 14. Pacientes con diagnóstico actual de colitis ulcerosa o colitis indeterminada,establecida por el investigador y el monitor médico de Abbott. 15. Pacientes con ostomía o reservorio ileoanal (no se excluirá a los pacientes con anastomosis ileorrectal), fístula supurativa o absceso. 16. Pacientes con sínd. del intestino corto determinado por el investigador.17. Pacientes que reciban actualmente nutrición parenteral total (NPT).18.Pacientes que estén recibiendo nutrición enteral a través de una sonda para nutrición completa.19.Mujeres embarazadas, que estén pensando en quedarse embarazadas o que no suspendan la lactancia materna.20.Pacientes que hayan recibido algún producto químico o biológico experimental en los últimos 30 días o 5 semividas antes de la visita basal (lo que suponga más tiempo). 21. Pacientes que hayan recibido tratamiento antibiótico, antiviral o antifúngicosistémico en las 3 semanas previas al momento basal para infecciones no relacionadas con la enfermedad de Crohn. 22.Pacientes con antecedentes de alcoholismo o toxicomanía clínicamente significativos en el último año. 23.Pacientes con una enfermedad médica mal controlada, por ejemplo: diabetes no controlada con antecedentes documentados de infecciones recurrentes, cardiopatía isquémica inestable, insuficiencia cardíaca congestiva moderada a grave (clase III o IV de la NYHA), accidente cerebrovascular reciente y cualquier otro proceso que, en opinión del investigador o del promotor, supondría un riesgo para el paciente si participara en este estudio 24.Pacientes con resultado positivo en un análisis de C. difficile en heces.25.Los análisis de laboratorio y de otro tipo realizados en la selección muestran alguno de los siguientes resultados anormales:Electrocardiograma(ECG)con anomalías clínicamente significativas; Aspartato transaminasa(AST) o alanina transaminasa(ALT) > 2 x el límite superior del intervalo de referencia; Bilirrubina total >= 3mg/dl; Creatinina sérica >1,6mg/dl. 26. Pacientes que hayan recibido enemas terapéuticos en las 2 semanas previas al momento basal 27. Pacientes que hayan recibido ciclosporina (intravenosa, oral), tacrolimús o micofenolato mofetilo.28.Pacientes con hipersensibilidad conocida a los excipientes de adalimumab que se indican en la ficha técnica.29.Pacientes con antecedente de displasia del tubo digestivo o que presenten displasia en alguna biopsia realizada durante la endoscopia de selección.30.Pacientes que hayan recibido antiinflamatorios no esteroideos (AINE) en los 14 días previos a la selección. 31. Uso actual de alopurinol.32.Pacientes con contraindicación para la RM,como:marcapasos implantado, grapa para aneurisma no compatible con la RM, fragmentos metálicos: Pacientes con claustrofobia; accidentes con alergia a medios de contraste para recibirlos.33Disfunción renal en la selección con filtr. Glom. estimada < 60 ml/min empleandoecuación Cockcroft-Gault FGe
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de la eficacia es la proporción de pacientes con curación de la mucosa (CDEIS < 4) y ausencia de ulceraciones profundas en la ileocolonoscopia (ausencia total de ulceraciones profundas en todos los segmentos examinados en elCDEIS) en la semana 56.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    SEROLOGICO serologic
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    adalimumab versus terapia combinada
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 240
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-05
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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